Granules Pharmaceuticals Receives FDA Tentative Approval for Generic Amphetamine Extended-Release Tablets with 180-Day Exclusivity

Granules Pharmaceuticals, Inc., a subsidiary of Granules India Limited, has received Tentative Approval (TA) from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Amphetamine Extended-Release Tablets in strengths of 5 mg, 10 mg, 15 mg, and 20 mg. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and has an estimated market size of approximately USD 41 million. The Granules ANDA has been determined to be eligible for 180-day exclusivity by the FDA, reinforcing its growing capabilities in developing and commercializing complex and differentiated generic products for the U.S. market.